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April 2004

Analysis of Axillary/Subclavian/Innominant Vein Venoplasty or Micro-dissection: A Data Registry.

Principal Investigator: Seth J. Worley, MD

Objective: To analyze the clinical outcomes of patients undergoing micro-dissection and/or venoplasty of the axillary-subclavian-innominant vein during pacemaker or ICD upgrade/revision. Estimated number of subjects is 50.


Atrial Recordings During Implantation of Pacemakers: A Data Registry

Principal Investigator: Seth J. Worley, MD

Objective: To analyze the data recorded at the time of pacemaker/ICD implant to see if there is a significant correlation between the timing programmed using atrial recordings and timing determined by AV optimization echocardiography. Patients’ functional capacity will also be assessed. Estimated number of subjects is 75.


Chest X-ray Analysis of Lead Position Relative to Patient Functional Capacity: A Data Registry

Principal Investigator: Seth J. Worley, MD

Objective: To analyze pacemaker/defibrillator lead placements on chest x-rays and determine if there is a relationship between lead placement and the functional capacity, quality of life, and functional class of patients receiving these devices. Estimated number of subjects is 20.


D.E.S.cover Registry

Principal Investigator: Richard D. Gentzler, MD

Collaborators: The Heart Group

Sponsor: Cordis Corporation

Objective: Collection of data on all patients undergoing any PCI procedure to characterize the use of drug eluting stents and their outcomes; to compare the use of DES among hospitals and practices; to DES usage and their outcomes compared to PTCA alone and bare metal stents; to obtain economic, quality of life and clinical information.


Nonpharmacological Interventions in Behavior Disturbances in Cognitively Impaired Residents of Long Term Care Facilities

Principal Investigator: Leon Kraybill, MD

Collaborators: Mennonite Home Staff, Christi Stewart, MD

Sponsor: American Medical Director Association

Objective: Establish tools and programs to improve nonpharmacological management of inappropriate behavior. Develop an individualized treatment plan for the resident, based on his/her past history and current needs.


FUSION 2 – Follow-up Serial Infusions of Natrecor™ (nesirtide) for the Management of Patients with Heart Failure

Principal Investigator: Roy S. Small, MD

Collaborators: Joseluis Ibarra, MD, Mark D. Etter, MD, Jon Echterling, CRNP, Lisa

Rathman, CRNP, Sherri Delgado, CRNP, Lynn McGrory, CRNP

Sponsor: Scios, Inc.

Objective: Patients are randomly assigned to receive either once or twice a week infusions of Natrecor or placebo for 12 weeks followed by a 4 week weaning period and an 8 week assessment period to evaluate the safety and efficacy of Natrecor in the outpatient setting.